PLIMATH

PLIMATH

A Phase II Study to Determine Pembrolizumab as Frontline Treatment of Patients With Hodgkin Lymphoma (PLIMATH)

Disease:

Hodgkin Lymphoma

Summary:

Hodgkin lymphoma is an aggressive form of lymphoma, which is a cancer of the immune system. Symptoms include enlarged lymph nodes, fevers, drenching sweats (particularly at night), weight loss and itching.

There are very effective chemotherapy options available to treat Hodgkin lymphoma, but in some people these may not be suitable or safe to use (eg. Older people, or people with other health conditions).

The immune system is the body’s first line of defence against cancer. There are novel non chemotherapy drugs being developed for treating Hodgkin lymphoma, which target different parts of the immune system. This type of treatment is known as immunotherapy. One group of immunotherapy drugs being developed are PD-1 inhibitors. The PD-1 pathway is part of the immune system, and is involved in the interactions of T cells (one type of white blood cell) with cancer cells. PD-1 inhibitors can increase the activity of T cells to detect and kill cancer cells.

This trial is for people who have Hodgkin lymphoma which has not yet been treated, and for whom the standard chemotherapy regimen is not suitable. The aim of the study is to evaluate the safety and effectiveness of a PD-1 inhibitor called Pembrolizumab.

Eligibility:

Include, but not limited to, the following:

Including but not limited to the following,
- A diagnosis of Hodgkin lymphoma, with stage III or IV disease (plus some types of stage II disease).
- No previous treatment received for Hodgkin lymphoma
- EITHER a) 65 years old or above
- OR b) Over the age of 18 years and not suitable to receive the standard chemotherapy regime known as ABVD.
- No serious medical conditions
- No active cancers in the last two years (except some cancers that have been cured with minor operations eg. Skin cancer)

Contact person:

Alex Zagwocki, Clinical trials Coordinator, Linear Clinical Research

Email azagwocki@linear.org.au

Phone

Principal Investigator:

Dr Chan Cheah

Sponsor:

Peter Maccullum Centre, Melbourne

Phase:

II

Protocol Number:

LO180502

Trial Registration Number:

NCT03331731

Clinical Trials.gov

ANZ Clinical Trial Registry